Hypertension Resistant to Conventional TherapyPhase 2SCRATCHNCT02653222
Chemical Renal Ethanol Sympatholysis Under CT Guidance Use for the Control of Therapy-Resistant Hypertension
A Phase 2 study testing Renal sympathicolysis, Ambulatory Blood Pressure Monitoring and Magnetic Resonance Angiography in people with Hypertension Resistant to Conventional Therapy and Kidney Failure, Chronic, run by University Hospital, Grenoble at 2 sites in France.
Trial summary
In this study the investigators are going to assess the feasibility of this innovate technique of renal sympathetic denervation by translumbar access under ct-guidance. To limit the potential impact on the kidney, the investigators chose a population of chronic renal failure patients on dialysis or renal transplant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension Resistant to Conventional Therapy, Kidney Failure, Chronic
- What is being tested?
- Renal sympathicolysis, Ambulatory Blood Pressure Monitoring and Magnetic Resonance Angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2016to Feb 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- more or equal than 18 years old,
- patient with triple antihypertensive therapy (maximum tolerated dose) with a diuretic, except for anuric patients, and without modification treatment:
- in the last two months,
- expected in the next three months,
- renal transplanted patients with native kidneys followed for hypertension before transplant, and having a arterial systolic pressure ≥ 160 mmHg on the average of 3 measurements taken during the screening consultation and during at least one previous consultation OR
- chronic renal failure patient with dialysis and having a arterial systolic pressure ≥ 160 mmHg on the average of 3 measurements taken during the screening consultation and during at least one previous consultation
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- patient affiliated to social security or similarly regime
- patient who signed the consent to participate in the study
- No Inclusion Criteria:
- renal artery anatomy against-indicating the procedure including:
- 3 homolateral renal arteries
- kidney surgery including bypass surgery or renal artery reimplantation
- volume-dependent type of hypertension
- secondary hypertension (not included nephropathy)
- orthostatic hypotension associated with symptoms during the previous year
- medical history including:
- acute coronary syndrome, unstable angina, stroke within 6 months preceding the period of inclusion,
- surgery scheduled on the kidney, the renal arteries or the retroperitoneum during patient participation in the study period
- chronic alcoholism
- anticoagulants or antiplatelet agents for which a therapeutic window can not be considered (except aspirin dose less than or equal to 160mg / day)
- contraindication to the realization of an MRI
- included in another trial assessing a medicament or a medical device or a surgical procedure
- protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital
Grenoble, Isère, 38043
Grenoble Association for the Dialysis of Uremic Chronicles
La Tronche, Isère, 38700
About this study
Official title: Feasibility Study of Perivascular Computer Tomography-guided Ethanol Sympatholysis for the Treatment of Therapy-resistant Arterial Hypertension
In this study the investigators are going to assess the feasibility of this innovate technique of renal sympathetic denervation by translumbar access under ct-guidance.
To limit the potential impact on the kidney, the investigators chose a population of chronic renal failure patients on dialysis or renal transplant (with native kidneys still present) and having resistant treatment hypertension despite antihypertensive combination therapy well conducted.
The investigators expect to obtain a decrease of the blood pressure at the 24-hours ambulatory blood pressure monitoring (ABPM) one month after the sympathetic denervation.
- Being tested
- Renal sympathicolysis, Ambulatory Blood Pressure Monitoring, Magnetic Resonance Angiography, Blood test
- Keywords
- Ethanol Sympathicolysis, Computer Tomography guidance, Denervation, Kidney Transplantation, Dialysis
- Medical subject headings
- Hypertension Resistant to Conventional Therapy, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal sympathicolysisProcedure or surgery
Also called renal sympathetic denervation, CT guidance
Ambulatory Blood Pressure MonitoringProcedure or surgery
Also called ABPM
1 month before and after surgery the patient will have an ABPM over 24h
Magnetic Resonance AngiographyRadiation
Also called MRA
1 month before and after surgery the patient will have a MRA
Blood testBiological
complete blood count, blood platelets, coagulation profile, irregular agglutinins search
| Study group | Role | What they receive |
|---|---|---|
| Renal sympathicolysis | Experimental | The patient will have:
1. Ambulatory Blood Pressure Monitoring
2. Magnetic Resonance Angiography
3. Blood test
4. Renal sympathicolysis
5. Ambulatory Blood Pressure Monitoring
6. Magnetic Resonance Angiography Receives: Procedure: Renal sympathicolysis; Procedure: Ambulatory Blood Pressure Monitoring; Radiation: Magnetic Resonance Angiography; Biological: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success or failure of the peri-arterial technique injection of ethanol under CT guidance.
Assess the technical feasibility of a new procedure of renal denervation chemical sympatholysis with ethanol, by a translumbar access, guided by CT, in a population of chronic dialysis or transplant failure patients followed for resistant treatment hypertension.
The measure is a score based on the distribution of the ethanol near the aorta-renal angle
Measured: 2 hours
Secondary outcomes (4)
Any clinical adverse event, radiological or biological related to the procedure and between it and the end of the study (MRI and follow up to 1 month).
Assess the occurrence of adverse events in the population who received the intervention by chemical sympatholysis during the month following the intervention
Measured: One month
Change of the blood pressure between baseline and 1 month after surgery The results of this difference is in mmHg.
Assess the effect of the chemical kidney sympatholysis on blood pressure one month after surgery.
Measured: baseline at one month before surgery and 1 month after surgery
Duration of the procedure between the first scanner acquisition and the latest acquisition of control. The result is in minutes.
Assess the duration of the chemical sympatholysis procedure by translumbar access under CT guidance
Measured: 2 hours
A score will be established with one point by angle aorto-renal upper cover and one point on each quarter of the circumference of renal artery covered with ethanol.
Assess at 1 month follow up the chemical sympatholysis effect on blood pressure based on the distribution of ethanol (visualized by prior injection of contrast medium).
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Why it stopped: patient recruitment is difficult
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension Resistant to Conventional TherapyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien Ghelfi, Md, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653222
- Sponsor's protocol ID
- 38RC15.182
- Other IDs
- 2015-002579-59, 2015
- Acronym
- SCRATCH
- Status last verified
- May 2018
- First submitted
- 5 Jan 2016
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Perivascular Computer Tomography-guided Ethanol Sympatholysis for the Treatment of Therapy-resistant Arterial Hypertension
- ClinicalTrials.gov ID
- NCT02653222
- Acronym / sponsor ID
- SCRATCH / 38RC15.182
- Keywords
- Ethanol Sympathicolysis, Computer Tomography guidance, Denervation, Kidney Transplantation, Dialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: patient recruitment is difficult
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the investigators are going to assess the feasibility of this innovate technique of renal sympathetic denervation by translumbar access under ct-guidance.
To limit the potential impact on the kidney, the investigators chose a population of chronic renal failure patients on dialysis or renal transplant (with native kidneys still present) and having resistant treatment hypertension despite antihypertensive combination therapy well conducted.
The investigators expect to obtain a decrease of the blood pressure at the 24-hours ambulatory blood pressure monitoring (ABPM) one month after the sympathetic denervation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal sympathicolysis | Experimental | Procedure: Renal sympathicolysis, Procedure: Ambulatory Blood Pressure Monitoring, Radiation: Magnetic Resonance Angiography, Biological: Blood testThe patient will have: 1. Ambulatory Blood Pressure Monitoring 2. Magnetic Resonance Angiography 3. Blood test 4. Renal sympathicolysis 5. Ambulatory Blood Pressure Monitoring 6. Magnetic Resonance Angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- more or equal than 18 years old,
- patient with triple antihypertensive therapy (maximum tolerated dose) with a diuretic, except for anuric patients, and without modification treatment:
- in the last two months,
- expected in the next three months,
- renal transplanted patients with native kidneys followed for hypertension before transplant, and having a arterial systolic pressure ≥ 160 mmHg on the average of 3 measurements taken during the screening consultation and during at least one previous consultation OR
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal sympathicolysisAlso: renal sympathetic denervation, CT guidance | Procedure or surgery | Renal sympathicolysis |
| Ambulatory Blood Pressure MonitoringAlso: ABPM1 month before and after surgery the patient will have an ABPM over 24h | Procedure or surgery | Renal sympathicolysis |
| Magnetic Resonance AngiographyAlso: MRA1 month before and after surgery the patient will have a MRA | Radiation | Renal sympathicolysis |
| Blood testcomplete blood count, blood platelets, coagulation profile, irregular agglutinins search | Biological | Renal sympathicolysis |
Primary outcome
Success or failure of the peri-arterial technique injection of ethanol under CT guidance.
Time frame: 2 hours
Assess the technical feasibility of a new procedure of renal denervation chemical sympatholysis with ethanol, by a translumbar access, guided by CT, in a population of chronic dialysis or transplant failure patients followed for resistant treatment hypertension. The measure is a score based on the distribution of the ethanol near the aorta-renal angle
4 secondary outcomes
Any clinical adverse event, radiological or biological related to the procedure and between it and the end of the study (MRI and follow up to 1 month).
Time frame: One month
Change of the blood pressure between baseline and 1 month after surgery The results of this difference is in mmHg.
Time frame: baseline at one month before surgery and 1 month after surgery
Duration of the procedure between the first scanner acquisition and the latest acquisition of control. The result is in minutes.
Time frame: 2 hours
A score will be established with one point by angle aorto-renal upper cover and one point on each quarter of the circumference of renal artery covered with ethanol.
Time frame: One month
Results and safety
The study was stopped early (reason given: patient recruitment is difficult). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien Ghelfi, Md principal investigator
University Hospital, Grenoble
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Renal sympathicolysis, Ambulatory Blood Pressure Monitoring and Magnetic Resonance Angiography in people with Hypertension Resistant to Conventional Therapy and Kidney Failure, Chronic, run by University Hospital, Grenoble at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: patient recruitment is difficult). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success or failure of the peri-arterial technique injection of ethanol under CT guidance. (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.